RECRUITING

Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

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Conditions

Bladder CancerUrinary Bladder NeoplasmUrologic NeoplasmsNeoplasmsUrinary Bladder DiseasesFiducial markerFiducial marker guided technique

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.

Official Title

Bladder Fiducial Markers and Multiparametric-MRI (mp-MRI) to Optimize Bladder Chemo-radiotherapy

Quick Facts

Study Start:2020-07-01
Study Completion:2025-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04442724

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern.
  2. * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder
  3. * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation
  4. * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min
  5. * Ability to understand and willingness to sign a written informed consent
  6. * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation
  7. * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  1. * Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed
  2. * Known distant metastatic disease (e.g. pulmonary or hepatic metastases)
  3. * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed
  4. * Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection)
  5. * Planned (or prior history of) definitive bladder irradiation
  6. * Intravesical chemo- or biologic therapy within 6 weeks of first treatment
  7. * Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion
  8. * Clinically significant active infection or uncontrolled medical condition that would preclude participation in study
  9. * Pregnant or nursing women are excluded
  10. * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment
  11. * Individuals with severe renal failure and cannot receive MRI contrast

Contacts and Locations

Study Contact

Laura Sarmiento, CCRP
CONTACT
310-423-4295
laura.sarmiento@cshs.org

Principal Investigator

Maurice Garcia, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center (CSMC)
Los Angeles, California, 90048
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
Harvard School of Medicine/Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Maurice Garcia, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-01
Study Completion Date2025-04

Study Record Updates

Study Start Date2020-07-01
Study Completion Date2025-04

Terms related to this study

Keywords Provided by Researchers

  • Fiducial marker
  • Fiducial marker guided technique

Additional Relevant MeSH Terms

  • Bladder Cancer
  • Urinary Bladder Neoplasm
  • Urologic Neoplasms
  • Neoplasms
  • Urinary Bladder Diseases